# A Phase II Study of Cytokine Induced Memory-like (CIML) Natural Killer (NK) Cell Adoptive Therapy after Haploidentical Donor Hematopoietic Cell Transplantation.

> **NIH NIH UG1** · WASHINGTON UNIVERSITY · 2022 · $165,722

## Abstract

Abstract
 The Bone Marrow Transplant (BMT)/Leukemia Program at Washington University ranks among the
largest in the United States, performing over 400 transplants annually, including over 200 allogeneic
transplants. The program has been affiliated with the BMT Clinical Trials Network (CTN) since its inception,
initially as part of the Case Western Consortium, and more recently as a Core Center since 2011. During this
time, our institution has made significant contributions to CTN through clinical trials accrual and trial design
input. As part of this application for renewal as a Core Clinical Center, we propose a phase II clinical trial
incorporating the use of a novel cellular therapy into a haploidentical transplant platform for elderly patients
with relapsed refractory AML. The basis for this proposal is the demonstration that NK cells stimulated ex vivo
with a cocktail of cytokines (IL12, IL15, IL18), exhibit an enhanced memory–like response to subsequent AML
cell exposure both in vitro and in vivo in a mouse xenograft model. These observations led to a phase I dose-
finding clinical trial to establish safety of haploidentical cytokine-induced memory-like (CIML) NK cells as
therapy for elderly adults with relapsed AML, which has been concluded, and an ongoing phase II trial to define
efficacy, with favorable preliminary results. On this basis, we propose to incorporate this CIML NK cell
approach into a backbone of haploidentical donor stem cell transplantation with reduced intensity conditioning
and post-transplant cyclophosphamide for elderly adults with relapsed AML. Our hypothesis is that this
strategy will lower the incidence of relapse in this high risk population while preserving the tolerability of the
reduced intensity conditioning approach. Completion of this study would require accrual of 30 patients,
anticipated over a 2-year period in the context of a multi-center trial.

## Key facts

- **NIH application ID:** 10430084
- **Project number:** 5UG1HL109137-12
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** PETER WESTERVELT
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $165,722
- **Award type:** 5
- **Project period:** 2017-07-27 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10430084

## Citation

> US National Institutes of Health, RePORTER application 10430084, A Phase II Study of Cytokine Induced Memory-like (CIML) Natural Killer (NK) Cell Adoptive Therapy after Haploidentical Donor Hematopoietic Cell Transplantation. (5UG1HL109137-12). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10430084. Licensed CC0.

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